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Fluoxetine Shows No Benefit on Functional Outcome in Post Stroke Patients

A secondary analysis of the EFFECTS (Efficacy of Fluoxetine – a randomized Controlled Trial in Stroke) study suggests that the use of fluoxetine following stroke shows no benefit for functional outcome after 1 year and could potentially affect memory and communication.

Fluoxetine Shows No Benefit on Functional Outcome in Post Stroke Patients
Photo: Fluoxetine | InStyleHealth

What is Fluoxetine?

Fluoxetine is a type of antidepressant in a class of medications called selective serotonin reuptake inhibitors or SSRIs. This medicine works by increasing the amount of serotonin, which is a natural substance in the brain that helps maintain mental balance.

Fluoxetine is often used to treating depression, and in bulimia, and also in obsessive-compulsive disorder or OCD. It also helps many people recover from depression, and it has fewer unwanted side effects compared with older antidepressants.

This antidepressant medication is available only on prescription where it comes as capsules and tablets.

What Are The Side Effects of Fluoxetine?

Fluoxetine can cause side effects in some people, just like any medications; however, most people have no side effects or only minor ones. Common side effects of fluoxetine will subsequently improve as the body gets adapted to it.

Common Side Effects of Fluoxetine

Common side effects of fluoxetine happen in more than 1 in 100 people. Keep taking the medicine; however, one must tell their doctor if the side effects do not go away. The following are the common side effects:

  • Being unable to sleep
  • Diarrhea
  • Feeling sick (nausea)
  • Feeling tired or weak
  • Headaches

Serious Side Effects of Fluoxetine

Although this may happen rarely (in less than 1 in 100 people); however, there are  some people who may have serious side effects when taking fluoxetine.

EFFECTS covered 1,500 stroke survivors with average age of 71 years, where 38.3% were women, who had been randomized to receive 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. Current analysis was performed to determine if any effects of fluoxetine were maintained or delayed over 12 months or 1 year.

The modified Rankin Scale data were available for 95% of the overall population of the study. There were 4.1% of the participants who were lost to follow-up, and 4.5% died within 1 year.

In primary study outcome, the distribution of mRS categories was similar in the fluoxetine and placebo groups.

With regards to secondary outcomes, patients who received fluoxetine vs placebo had poorer scores on some domains of the Stroke Impact Scale, namely memory and communication.

Results on memory and communication with fluoxetine is said to be likely due to chance. Ongoing meta-analysis of individual patients data from EFFECT and other trials will reveal more precise estimates of any effects of fluoxetine.


Source: Stroke 2021;doi:10.1161/STROKEAHA.121.034705

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